The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

7801–7825 of 52968

  • HighFDA (Food)·F-1716-2024·2024-08-14

    Panaderia Guatemex Corona Bread Recalled for Undeclared Soy Allergen

    Panaderia Guatemex is recalling Corona brand bread packaged in plastic bags due to undeclared soy allergen. The affected product was distributed in Georgia, Kentucky, and Tennessee.

    Product
    Panaderia Guatemex - Corona packaged in plastic bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2492-2024·2024-08-14

    Automated Medication Cabinet Software Bug May Print Wrong Bin Labels

    CareFusion's BD PYXIS MEDBANK medication dispensing cabinets (software 3.9.1.9) have a software defect that may cause restock labels to print incorrect medication bin locations, creating a risk of medication dispensing errors.

    Product
    BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2024·2024-08-14

    Everest Bipolar Cutting Forceps Recalled for Potential Sterility Breach

    Olympus is recalling Everest Bipolar Cutting Forceps due to fractures and breakages in packaging trays and Tyvek covers that may result in a sterility breach. Approximately 6985 units are affected and were distributed worldwide.

    Product
    The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2493-2024·2024-08-14

    Medication dispensing cabinet software issue causes incorrect medication bin labels

    A software issue in BD PYXIS MEDBANK automated medication dispensing cabinets can cause incorrect medication bin labels on restock labels, potentially leading to medication storage errors.

    Product
    BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1664-2024·2024-08-14

    Palmer Patriotic White Fudge Cookies Recalled for Potential Salmonella

    Palmer & Company is recalling Palmer Patriotic White Fudge Cookies in 7oz and 13.5oz sizes due to potential salmonella contamination. Affected products were distributed nationwide in the United States and Canada.

    Product
    1. Palmer Patriotic White Fudge Cookies, Net Wt. 7oz, UPC 7723237084, 16/7oz case 2. Palmer Patriotic White Fudge Cookies, Net Wt. 13.5 oz, UPC 7723237085, 8/13.5oz case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2489-2024·2024-08-14

    BD PYXIS MEDBANK Automated Cabinet May Print Incorrect Medication Bin Labels

    A software issue in the BD PYXIS MEDBANK automated medication dispensing cabinet can cause incorrect bin labels to be printed for restock operations. This could lead to medication administration errors affecting patient safety.

    Product
    BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2514-2024·2024-08-14

    Diagnostic Test Kits Recalled for False Vibrio Results With Certain Transport Medium

    BioFire Diagnostics is recalling gastrointestinal diagnostic test kits due to false positive Vibrio results when used with certain transport mediums.

    Product
    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnost
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1674-2024·2024-08-14

    Nuts.com Ground Sumac Products Recalled for Undeclared Gluten

    Nuts.com is recalling Ground Sumac products due to undeclared gluten. Products were distributed online to consumers in multiple U.S. states, Canada, and the U.S. Virgin Islands.

    Product
    Nuts.com Ground Sumac 1 lb resealable stand-up pouches and 20 lb double lined plastic bags in a cardboard box.
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-2536-2024·2024-08-14

    Steris Hookup Model 2-8-540 Documentation Error Risks Improper Endoscope Disinfection

    Steris Hookup Model 2-8-540 instructions were incorrectly documented, potentially preventing proper endoscope disinfection and risking patient infection.

    Product
    Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2537-2024·2024-08-14

    Medical Device Hookup Instructions Incorrect, Risking Endoscope Disinfection

    Steris Corporation recalls 129 Hookup devices (Model 2-8-540HAN) due to incorrect hookup instructions in product documentation. Using wrong connections may prevent proper endoscope disinfection, creating infection risk.

    Product
    Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2508-2024·2024-08-14

    Philips IntelliVue Patient Monitor Software Missing Critical Entitlements

    Philips IntelliVue Patient Monitor models with software L.x and M.x lack critical monitoring capabilities due to a software update. This could result in incorrect or delayed patient treatment.

    Product
    IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2464-2024·2024-08-14

    GE Discovery MR750 MRI System Software May Cause Implant Overheating

    GE HealthCare is recalling certain MR750 MRI systems with specific software versions. When using particular imaging sequences in Low SAR Mode without the Optimized T2 FLAIR option, the radiofrequency field can exceed safe limits, risking overheating of MR-conditional implants.

    Product
    Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1643-2024·2024-08-14

    Izzio Everything Rolls recalled for potential plastic contamination

    Izzio Artisan Bakery is recalling Izzio Everything Rolls due to potential plastic contamination. Affected lot numbers are 24183C and 24183A.

    Product
    Izzio Everything Roll packaged in 12oz plastic bag, 6 rolls per bag - 16 bags per case.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1650-2024·2024-08-14

    Premo Turkey & Swiss 6oz Deli Meat Recalled for Potential Salmonella

    Lipari Foods is recalling Premo Turkey & Swiss 6oz deli meat packages due to potential Salmonella contamination. No illnesses have been reported.

    Product
    Premo Turkey & Swiss 6oz, clear plastic, UPC 612510001042, 4 retail packages per wholesale case
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-2502-2024·2024-08-14

    Automated Dispensing Cabinet Software Issue Causing Incorrect Medication Bin Labels

    A software defect in the BD PYXIS MEDBANK automated dispensing cabinet causes incorrect medication bin locations to be printed on restock labels, potentially resulting in medication dispensing errors. No illnesses or injuries have been reported.

    Product
    BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2462-2024·2024-08-14

    GE SIGNA Premier MRI system software overheating risk to implants

    GE Medical Systems is recalling 404 SIGNA Premier MRI systems worldwide due to a software issue where radiofrequency energy can exceed prescribed safety limits during specific imaging sequences, potentially overheating MR-conditional implants.

    Product
    SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2468-2024·2024-08-14

    GE MR450w 1.5T MRI software defect may cause implant overheating

    GE MR450w 1.5T MRI systems may overheat MR-conditional implants when using specific imaging sequences with Low SAR Mode. No injuries reported; 1,607 units affected worldwide.

    Product
    Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2518-2024·2024-08-14

    Gyn Laparoscopy Kits Recalled Due to Inadequate Sterilization Process

    American Contract Systems is recalling 29 gynecological laparoscopy surgical kits due to insufficient aeration during sterilization, which may compromise sterility and increase infection risk for patients.

    Product
    American Contract Systems Gyn Laparoscopy convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1641-2024·2024-08-14

    Black Forge Kitchen Knives Recalled for Elevated Lead Levels

    Black Forge Knives is recalling multiple kitchen knife models distributed in Georgia and via Bespoke Post due to elevated lead levels in the blades.

    Product
    1- Name: Carbon Steel Utility Kitchen Knife Model: CSK1700 Size: Total length: 10.25" Type of packaging: Each knife packed in a single box 2- Name: Carbon Steel Utility Kitchen Cleaver Knife Model: CSK1701 Size: Total length: 10.5" Type of pac
    Category
    Consumer Product
    Distribution
    1 state
  • HighFDA (Devices)·Z-2497-2024·2024-08-14

    BD PYXIS MEDBANK Medication Cabinet Software Issue Causes Incorrect Bin Labels

    CareFusion is recalling BD PYXIS MEDBANK medication dispensing cabinets due to a software issue that causes incorrect bin information to print on restock labels, potentially leading to medication selection errors.

    Product
    BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2517-2024·2024-08-14

    American Contract Systems Hand Pack Convenience Kit Sterilization Failure

    American Contract Systems is recalling Hand Pack convenience kits that may not be sterile due to insufficient aeration time during sterilization. Affected devices distributed in CA, KS, ME, MN, MO, NE, and SD may pose a safety risk.

    Product
    American Contract Systems Hand Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V606000·2024-08-13

    Cruiser Stryker Travel Trailers Recalled for Generator Venting Defect

    Cruiser RV is recalling 2024-2025 Stryker travel trailers with optional Onan 5.5 generators due to improper venting that may cause overheating or trapped exhaust.

    Product
    CRUISER — CRUISER STRYKER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V607000·2024-08-13

    Motorhome Overhead Cabinet Fasteners May Break and Cause Detachment

    Motorhomes with HappiJac drop-down beds have front overhead cabinet fasteners that can break and detach while in motion. This can distract drivers and increase crash risk.

    Product
    FLEETWOOD — FLEETWOOD, HOLIDAY RAMBLER FLAIR, STORM, ADMIRAL XE, PACE ARROW
    Category
    Vehicle
    Distribution
    Distributed nationwide